We hear regularly as to what’s happening in Russia, Germany, India, China, the University of Oxford, in the UK, Sinovac Life Sciences trials in Brazil, Pfizer, Johnson and Johnson, and the studies being conducted by Astra Zeneca among other important trials
Very few of us however, have heard that on August 24, Cuban scientists at the the Finlay Vaccine Institute (IFV) announced that the country has started the first phase of human trials of the COVID-19 vaccine called "Soberana 01."
#Cuban #COVID19 #vaccine candidate in phase 1/2 trials: Meet the team who developed it, vaccinating themselves first. Finlay Vaccine Institute & Molecular Immunology Center,Havana. Bravo! @FinlayInstituto @centro_cim @ReviewMedicc @richardhorton1 pic.twitter.com/uIGBuZIdjc— GailReedMEDICC (@MediccGail) August 24, 2020
They began clinical trials of their Soberana 01 Vaccine with a group of 20 individuals ranging in age from 19 to 59 years.
On September 3, the vaccine was administered to another group of 20 volunteers whose ages ranged between 60 and 80 years.
Besides confirming that they are in good health, the volunteers indicated that a mild pain at the injection site was the only adverse effect.
On Sept. 11, the Cuban vaccine entered the next phase of clinical testing in which 676 volunteers participated. Although the investigation must conclude all its stages in January 2021, the results of the study will be available at the end of November.
Recently, Cuba’s Foreign Minister Bruno Rogrigues denounced what he said was a “media blockade”, at the international level on the country's success in confronting the COVID-19 pandemic.
Rodriguez took to Twitter to denounce that although Cuba continues to share its medical successes with the world, little information is shared on large media outlets.
"Cuban scientists share their progress with the world, show protocols against the pandemic and results of their own vaccine candidate. However, little information about this is shared. The Cuban agenda is biased. Ignoring or censoring successes is part of the media blockade," Rodriguez tweeted.
During an interview with national television program Mesa Redonda, Finlay Vaccine Institute (IFV) director Vicente Vérez explained that Cuba's vaccine candidate is the 30th to receive approval to go on clinical trials among 200 vaccines candidates worldwide.
"This is a milestone for Cuba's science, being able to come up with a vaccine candidate that's qualified to go on clinical trials and to achieve that in only 90 days", Vérez said as the average time to develop a vaccine candidate takes 10 to 15 years.
On the other hand, Yuri Valdéz Balbín deputy director at IFV detailed that the Soberana vaccine candidate is based on the protein RBD, an antigen that acts as a "key" to access the virus. This protein requires mammals cells based technology to be produced, something that Cuba's's Center for Molecular Immunology has widely develop for other products such as cancer vaccines.
The scientist remarked that the speedy development of this vaccine candidate was possible because, unlike other circumstances, in the context of the COVID-19 pandemic, all scientific information can be accessed for free. Furthermore, Cuba's decade's long experience in vaccine production allowed it to use existing platforms rather than start from cero.
The research director at IVF Dagmar García noticed that during the preclinical trial in mouses, rabbits, and hamsters, it emerged that seven days after the firsts dose, the levels of specifical antibodies against the RBD protein rose considerably. In this sense, the scientist explained that the capacity to generate particular antibodies against the virus only seven days later is one of the most outstanding qualities of this vaccine candidate.
The platform for the SOBERANA vaccine was created based on the Cuban Meningogococcal Vaccine, which has been used since its creation in 1989. In this sense, and unlike some medical approaches worldwide, Cuban scientists decided that the clinical trials will use the Meningococcal Vaccine for the control groups.
In Latin America, Cuba is the only country whose scientists have received authorization to conduct clinical trials of a domestically produced vaccine.
This technological achievement is the consequence of decades of accumulated research in preventive medicine and mass immunization. It is also the result of a biopharmaceutical industry with the capacity to compete with pharmaceutical transnationals.
The Pan American Health Organization (PAHO) said the Sovereign 01 vaccine could benefit the Latin American peoples when Cuban scientists finish developing it.
During a virtual meeting between directors of the Finlay Vaccine Institute, the PAHO experts mentioned this possibility as part of the international cooperation that Cuba could offer to guarantee universal access for Latin Americans to the vaccine against the new coronavirus.
PAHO’s representative in Cuba, Jose Montoya, says he hopes the Sovereign 01 medicine satisfies all the tests and rigorous protocols as soon as possible, as his organization will acquire the medicine to make it available to other countries.
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